Kornimate/medical-research-clean huggingface dataset:
pkc412 in participants with acute myeloid leukemia or with myelodysplastic syndrome (cpkc412a2104 core); and pkc412 in participants with acute myeloid leukemia or with myelodysplastic syndrome with either wild type or mutated fms-like tyrosine kinase 3 (flt3) (cpkc412a2104e1 and cpkc412a2104e2)

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes

Summary: cpkc412a2104 core had a 2 stage design. in stage 1, eight participants were treated. if at least one participant showed a clinical response, four more participants were recruited to stage 2. the trial was to be stopped if no participants showed a response in stage 1. poc was achieved if at least 2 participants out of 12 responded. in pkc412a2104e1, participants with aml or high risk mds with wild-type or mutant ftl3 who had not previously received a flt3 inhibitor were randomized to receive continuous twice daily oral doses of either 50 or 100 mg midostaurin in 1 28-day cycle regimen. participants were to be treated until disease progression or the occurrence of unacceptable treatment-related toxicity. pkc412a2104 e2 contained 2 dosing regimens: 1) intra-participant midostaurin dose escalation and 2) midostaurin with itraconazole in participants with aml and high risk mds irrespective of flt3 status. eligible participants were alternately assigned to the regimens. at the investigator's discretion, intra-participant dose escalation was allowed for any previously enrolled cpkc412a2104e1 participant receiving midostaurin at the time of the approval of amendment 4. participants were treated until the time of disease progression.


Eligibility criteria:
inclusion criteria: 1. patients: with aml who are not candidates for myelosuppressive chemotherapy or with aml who have relapsed disease or are refractory to standard therapy and not likely to require cytoreductive therapy within one month or with mds subtypes refractory anemia with excess blasts (raeb), raeb in transformation (raeb-t) or chronic myelomonocytic leukemia (cmml). 2. patients with a relevant flt3-itd mutation or d835y point mutation 3. patients at least 18 years or older 4. patients with who performance status of 0 to 2 with a life expectancy of at least 3 months 5. patients must not be treated within 4 weeks after any prior therapy 6. written informed consent obtained according to local guidelines exclusion criteria: patients meeting any of the following criteria during screening will be excluded from entry into the study: 1. patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant less than 2 months previously. 2. female patients who are pregnant or breast feeding, or adults of childbearing age not employing an effective method of birth control. 3. concurrent severe and/or uncontrolled medical or psychiatric condition which may interfere with the completion of the study. 4. impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of pkc412.

Keywords: aml mds high risk myelodysplastic syndrome
hmw-adiponectin is raised in newborns

Conditions: Pre-Eclampsia

Summary: cross sectional, hospital-based study dealing with adiponectin levels in newborns to mothers with pre-eclampsia. venus cord blood samples were collected immediately after birth; 30 cases and 62 controls were enrolled into the study. the study was approved by the local ethics committee and all participants gave written consent.


Eligibility criteria:
inclusion criteria: * pre-eclampsia

Keywords: adiponectin, cord blood, pre-eclampsia
molecular markers of prognosis in colorectal cancer patients

Conditions: Colorectal Cancer

Summary: to correlate the molecular profile of a series of defined crcs with prognosis and toxicity.


Eligibility criteria:
inclusion criteria: * all patients participating in the rmhnhst study of infusional versus bolus 5fu (saini et al. 2003).
bio-repository of high risk cohorts for the early detection of pancreas cancer

Conditions: Pancreatic Cyst; Pancreas Disease

Summary: bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2) patients at high risk, defined by family history and/or genetic mutations, for pancreatic cancer.

observational study to collect bio-specimens from 2 separate patient cohorts identified to be at high risk for subsequent development of pancreas cancer. 1. patients diagnosed with a pancreatic cyst undergoing either endoscopic ultrasound or surgery. bio-specimens collected include pancreatic cyst fluid and blood. these will be collected using a standard operating protocol. 2. patients defined as a high risk individual for pancreas cancer by family history and/or known genetic mutations. bio-specimens collected include blood. this will be collected using a standard operating protocol.

Eligibility criteria:
inclusion criteria: * older than 18 with pancreas cyst * older than 18 at high risk for pancreas cancer exclusion criteria: * unable to provide consent * not willing to provide bio-specimens

Keywords: early detection biomarkers pancreas cancer
long-term safety extension to study trca-301

Conditions: Metabolic Acidosis

Summary: this study is a 40-week, blinded, placebo-controlled extension of study trca-301 (nct03317444). eligible subjects who complete the 12-week treatment period in study trca-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of trc101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. eligible subjects will be treated with trc101 or placebo once daily (qd) on an out-patient basis for the subsequent 40 weeks. subjects will continue to receive the same blinded treatment (trc101 or placebo) that they received in study trca-301.


Eligibility criteria:
key inclusion criteria: * completed the 12-week treatment period and attended the week 12 visit in the parent study trca-301. * blood bicarbonate level of \>= 12 meq/l at the week 12 visit in the parent study trca-301. key exclusion criteria: * any level of low blood bicarbonate at the week 12 visit that, in the opinion of the investigator, requires emergency intervention or evaluation for an acute acidotic process. * required dialysis for acute kidney injury or worsening ckd during the parent study trca-301. * planned initiation of renal replacement therapy within 6 months following study entry. * history or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers. * serum calcium \<= 8.0 mg/dl at the week 10 in the parent study trca-301.

Keywords: blood bicarbonate, kidney disease
evolution of facial trauma during covid containment measures

Conditions: Maxillofacial Injuries; Skull Fractures; COVID-19

Summary: the covid-19 global pandemic has led to a major professional and social national reorganization: professional because it involves a redeployment of medical staff and material resources, and social because it imposes prolonged containment measures on an entire population. the maxillofacial trauma activity is mainly linked to sports or leisure accidents, fights and road accidents. it seems to appear since the beginning of containment measures a significant drop in maxillofacial trauma activity at the national level, which, if it is demonstrated in a significant way in several french hospital centers, would allow to redeploy the material and human resources related to this activity on sectors in tension due to the pandemic.

this study will compare maxillo-facial activity during the first month of covid-19 containment measures in france with a comparable period in 2018 and 2019. this comparison will be made in 10 major french hospital centers.

Eligibility criteria:
inclusion criteria: * maxillo-facial fracture * requiring * trauma that occured between march 16 and april 15, 2020 or 2018 or 2019 * all ages exclusion criteria: * patients who refused the collection of their data

Keywords: pandemics maxillofacial fractures facial trauma containment quarenteen outbreak
cartilaginous batten graft septoplasty in caudal septal deviation

Conditions: Nasal Septal Deviation

Summary: to evaluate the clinical outcomes of septoplasty using cartilaginous batten graft in cases with caudal septal deviation as regards the relieve of nasal obstruction and aesthetic results.

a prospective study will be conducted over 15 patients indicated for septoplasty. preoperative assessment: history * nose (nasal obstruction septoplasty effectiveness score): higher nose scores indicate worse nasal obstruction (range: 0-100). * visual analogue scale (vas) (0-10) of nasal obstruction:for nasal obstruction examination: * anterior rhinoscopy: to confirm caudal septal deviation. * endoscopic nasal examination: to exclude hit, polyp, mass and discharge. * basal view photograph. * ct nose and paranasal sinuses to exclude other pathology. operative procedures: * general anesthesia. * hemitransfixtion incision on the concave side * the mucoperichondrial flap of the septum will be elevated * a contralateral flap will be elevated from the caudal aspect of the cartilage * subperichondrial dissection into the nasal floor * the curved portion of the septal cartilage will be harvested by excision, leaving an l-strut of dorsal and caudal cartilaginous septum * a caudal septal batten graft created from harvested septal cartilage, then will be sutured using three or four stitches (5-0 polydioxanone sutures). * if c-shaped caudal deviation without angulation or dislocation, cartilaginous batten graft fixed on the concave side * if there is angulation of caudal septal end, the caudal strut will be cut by scissors at the most convex point in the caudocephalic direction. excessive lower and upper caudal struts will be overlapped and sutured together with batten graft * if dislocated, the septal cartilage will be separated from the anterior nasal spine (ans) and maxillary crest for reposition. if there is an excessive cartilage portion, it will be removed and then the graft will be sutured * the hemitransfixion incision will be closed using 5-0 vicryl * internal nasal splint and anterior nasal pack will be placed in both sides

Eligibility criteria:
inclusion criteria: - patient presented with nasal obstruction or disfigurement due to anterocaudal septal deviation. exclusion criteria: * previous septal surgery * deformed nose, which necessitate external rhinoplasty approach. * other endonasal cause of nasal obstruction other than deviated nasal septum * bleeding disorder or systemic diseases. * patient who will not complete the follow up periods.

Keywords: caudal septal deviation batten graft septoplasty
pulse pressure variation (ppv) to predict fluid responsiveness during cardiac displacement in patients undergoing off-pump coronary artery bypass surgery (opcab)

Conditions: Ischemic Heart Disease

Summary: pulse pressure variation (ppv) known as a dynamic preload index is increasingly being used for guide of fluid management under various clinical situations. we hypothesized that ppv could play a role as a predictor of fluid responsiveness during displacement of the heart in patients undergoing off-pump coronary artery bypass surgery (opcab).

the aim of this study was to investigate the ability of ppv to predict fluid responsiveness during displacement of the heart in patients undergoing off-pump coronary artery bypass surgery. after anesthesia, we will measure mean arterial pressure, heart rate, central venous pressure, mean pulmonary artery pressure, pulmonary arterial occlusion pressure, mixed venous oxygen saturation, ppv and cardiac index in patients receiving elective opcab. all parameters will be recorded at 5 minutes after the left anterior descending artery anastomosis, immediately after the displacement of the heart for the left circumflex artery anastomosis, and 10 minutes after fluid loading with hydroxyethyl starch 6%(10 ml/kg). patients whose cardiac index increased by \>15% to fluid loading will be defined as responders. to test the abilities of central venous pressure, pulmonary artery occlusion pressure and ppv to predict fluid responsiveness during heart displacement, areas under the receiver operating characteristics curves of the responders will be calculated and compared.

Eligibility criteria:
inclusion criteria: * patients undergoing elective off-pump coronary artery bypass surgery exclusion criteria: * unstable angina, preoperative arrhythmia, reduced ventricular function (ejection fraction \< 40%), more than mild degree valvular heart disease, preoperative use of vasopressors or mechanical assist devices, intra-cardiac shunt, pulmonary artery hypertension, severe peripheral vascular obstructive disease, or esophageal pathology precluding the use of transesophageal echocardiography (tee)
shift worker intervention for sleep health

Conditions: Shift Work Type Circadian Rhythm Sleep Disorder; Insomnia, Psychophysiological

Summary: the aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("swish") designed to improve sleep health among shift workers.

night shift nurses with insomnia who meet all study criteria will receive insomnia therapy, modified for shift workers that is designed to improve sleep health among shift workers by targeting shift workers' unique sleep health problems which manifest during both sleep and wake. participants will be randomized to either swish, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across approximately weekly sessions that range in length from 30-60 minutes, or delayed treatment control, which will involve weekly assessments but no active treatment until the delay period is over, at which point they will be offered the intervention. the therapy will be conducted over telehealth by interventionists trained in behavioral sleep medicine.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * any gender; ages 18-65 * currently employed as a nurse or nursing staff member (e.g., cna) in the united states * currently have shift work schedules (i.e., stable night shift or rotating shifts that include nights, \>=2 nights/week) and have worked shift work \>=2 nights/week for at least 3 months * expect to have a shift work schedule \>=2 nights/week over the next 6 months * endorse poor sleep, as evidenced by t-score \>=60 on the promis sleep disturbance or sleep-related impairment measure * have daily access to the internet on a smartphone, table, or computer; and * can read and write in english. exclusion criteria: * conditions which make study treatment likely to be ineffective. for example, current chronic use of medications that interfere with sleep, alcohol or substance use disorder, or thought disorder (as determined by diamond psychiatric interview), unstable sleep or medical conditions that necessitate additional medical care not provided by study treatments (e.g., known untreated sleep apnea). * presence of safety risk or condition in which study participation may result in increased risk to safety (e.g., elevated risk for suicide, self-reported uncontrolled seizure disorder, history of manic or hypomanic episode, current pregnancy), * currently receiving non-pharmacological treatment for insomnia (e.g., cognitive behavioral therapy for insomnia) and/or current unstable hypnotic/alerting medication use or * currently participating in other research studies with substantial overlap in terms of methods/procedures (e.g., pi's ongoing study "piloting an adaptation of cognitive behavioral therapy for insomnia for shift workers (cbti-shift)"

Keywords: insomnia shift work nurse sleep psychology behavioral sleep medicine circadian rhythm
the effect of arthroscopic subacromial decompression in patients who are non-responders to non-operative treatment.

Conditions: Subacromial Impingement Syndrome

Summary: to investigate if glenohumeral arthroscopy and arthroscopic subacromial decompression is more effective than glenohumeral arthroscopy alone in improving patient-reported outcome at 12 months in patients with subacromial impingement syndrome (sis) who are non-responders to non-operative treatment.

the trial is designed as a patient and assessor-blinded, randomized, controlled trial with two parallel groups. participants are randomized 1:1 to either asad and glenohumeral arthroscopy (intervention group) or glenohumeral arthroscopy alone (control group). the two groups are subscribed identical postoperative rehabilitation consisting of 3 months physiotherapy in a municipally setting. the primary endpoint is the shoulder pain and disability index (spadi) 12 months after surgical intervention. the study will adhere to the consort guidelines. all participants will be recruited consecutively from the outpatient clinic, arthroscopic center, copenhagen university hospital, hvidovre. consultant orthopedic surgeons will conduct the initial eligibility screening as part of their consultation. eligible participants will be provided with thorough verbal and written information about the trial and their right to withdraw at any time. patients given their written, informed consent to participate in the trial, will receive scheduled appointments for the baseline examination.

Eligibility criteria:
inclusion criteria: * sis diagnosis (consultant's clinical diagnosis of sis + at least 3 out of 5 positive tests from the following: hawkin's, neer's, jobe's, painful arc and external rotation resistance test) * positive subacromial injection test * insidious onset of shoulder pain * considered a surgical candidate by an orthopedic shoulder specialist. * symptoms for at least 6 months * completion of at least 3 months supervised shoulder training * no improvement in symptoms for at least 3 months * the patient must be expected to be able to attend rehabilitation and post-examinations. exclusion criteria: * terminal illness or severe medical illness (asa score higher than or equal to 4), systemic musculoskeletal disease, inflammatory joint disease (e.g. rheumatoid arthritis), symptomatic cervical spine pathology or thoracic outlet syndrome. * full-thickness rotator cuff tear, calcified tendonitis, labral tear, frozen shoulder, biceps tendon pathology, acromioclavicular osteoarthrosis, glenohumeral osteoarthrosis or other concomitant shoulder pathology. * previous surgery or radiotherapy on the affected shoulder. * pregnancy * ongoing workers compensation case or job rehabilitation process
exploration of the deep transcranial magnetic stimulation for treatment resistant schizophrenia

Conditions: Treatment Resistant Schizophrenia Based on the DTMS

Summary: negative symptoms and cognitive dysfunction are of importance for the prognosis of the patients of schizophrenia. based on the hypothesis that deep transcranial magnetic stimulation(dtms) on prefrontal cortex #pfc# could down-regulate the glutamate level of pfc and regulate the functional network in patients with treatment resistance schizophrenia,this research plan to utilise multimodal functional magnetic imaging method(including structural mri,resting-state functional magnetic resonance imaging and 1h-mrs) to investigate therapeutic efficacy of high-frequency deep transcranial magnetic stimulation on sz patients symptoms,as well as to elucidate the correlation between treatment effects and glutamate level of pfc

this study includes 87 treatment resistance schizophrenia patients. this study will investigate 1)abnormalities of the glutamate level of pfc in patients with schizophrenia compared to healthy controls by using 1h-mrs technique. 2)potential modulation effects of deep transcranial magnetic stimulation(dtms) on prefrontal cortex function of patients with schizophrenia. 3)the therapeutic efficacy of dtms on cognitive impairments and other psychotic symptoms of patients with schizophrenia by adopting cognitive function and psychotic symptoms evaluation,as well as to explore the optimal dtms treatment pattern on cognitive function.

Eligibility criteria:
inclusion criteria: * patients with schizophrenia who meet the dsm-5 diagnostic criteria * aged from 18 to 55 * right-handedness, normal hearing, visual acuity or corrected visual acuity * written informed consent of the patient and his/her family * all patients received mini 7.0 structured interviews exclusion criteria: * patients who are currently taking clozapine or who have failed to respond to a full course of treatment with clozapine * current or past neurological illness,severe physical illness,substance abuse or addiction,alcohol dependence,mental retardation,pregnancy or lactation,extreme agitation, stupor, negative suicide,or those who can not cooperate * medically unstable for at least 1 month

Keywords: deep transcranial magnetic stimulation treatment resistant schizophrenia h1 coil
evaluation of a crowd-powered web platform for depression and anxiety

Conditions: Depression, Anxiety

Summary: 100 participants will be enrolled in a two-armed randomized controlled trial of the accumulated depression and anxiety plans and treatments (adapt) platform which integrates internet cognitive behavioral therapy (icbt) to determine impact on symptoms of depression and anxiety. this trial will pilot the effectiveness of the adapt platform, and evaluate the extent to which the adapt platform engages putative targets of personal relevance, skills use, and skills mastery.

the investigators will enroll 100 participants in a two-armed randomized controlled trial of the adapt platform (icbt). participants will be randomly assigned to receive either the adapt platform (treatment) or a similar self-guided platform (control) that contains the didactic material (learning) but lacks the adapt platforms "crowd" features. participants will use their assigned platform for a treatment period of 8 weeks. participants will receive trial assessments at baseline, week 4, and week 8 (post-treatment). follow-up evaluations will occur at 16 weeks to evaluate maintenance of gains. this pilot effectiveness trial aims to determine the impact on symptoms of depression and anxiety and whether the platform engages the putative targets of personal relevance, relationship, resulting in increased skills mastery and skills use.

Eligibility criteria:
inclusion criteria: * 1) completion of the mental health america screening to supports (mha s2s) or significant mood and anxiety symptoms as defined by an accepted cut-off on a validated measure the depression anxiety and stress scale (dass). the accepted cut-off is scores greater than 22; * 2) able to speak and read english; * 3) at least 18 years of age. exclusion criteria: * 1) severe suicidality (has ideation, plan, and intent)